Rick Doblin predicts MDMA-assisted therapy could win FDA approval by January.
The MAPS founder, 70, told The Post he is “very optimistic” about the timeline, though he admitted he is “willing to be disappointed — and we’ll keep trying.” His forecast centers on a resubmitted application from Resilient Pharmaceuticals, the company formerly known as Lykos Therapeutics, which handed new paperwork to the agency in August without conducting the additional Phase 3 trial regulators had demanded.
That omission would have seemed unthinkable two years ago, when Lykos appeared poised to make history with the first new PTSD treatment in more than two decades. The FDA crushed those hopes in August 2024, rejecting the bid over doubts about clinical trial reliability, safety risks and whether the studies proved effectiveness. The agency insisted on another Phase 3 study.
Doblin, who served on Lykos’s board before its rebranding, had seen trouble building long before the rejection. “Leading up to 2024, I saw a variety of ways in which the management of the company was not responding to the culture, not responding to the critics, not doing proactive things that they needed to do,” he told The Post, calling the collapse a “slow-motion train wreck,” He added: “I still was surprised that the FDA advisory committee said no and the FDA rejected it.”
The landscape has shifted dramatically since then. Resilient’s fresh filing leaned on outside research instead of fresh trials, including a small Veterans Affairs study with long-term follow-up, according to Psychedelic Alpha. MAPS confirmed the resubmission. The FDA permitted the application to advance anyway.
“The FDA has sort of put all their concerns on the table, and the company has addressed all those concerns, and the FDA has permitted the new drug application to go forward without another Phase 3 study — that was such a big thing,” Doblin explained.
Political tailwinds have strengthened too. President Trump signed an executive order in April directing federal agencies to accelerate psychedelic research. Health and Human Services Secretary Robert F. Kennedy Jr. Has backed fast-tracking such therapies. The FDA has also issued priority review vouchers to three companies developing psychedelic-based mental health treatments.
Military interest has surged as well. “A bigger thing, just from a cultural acceptance point of view, is that the Department of Defense is doing studies with active duty soldiers with PTSD with MDMA-assisted therapy,” Doblin noted. “I think there’s way more excitement now inside the VA.” Big Pharma has piled in too — Eli Lilly acquired AtaiBeckley for $2.8 billion in July, scooping up MDMA-based programs.
“I think it’s a completely different situation now,” Doblin said. At last week’s Beyond Psychedelics Conference in Austin, Texas, he told Dave Asprey’s event crowd there is a “very good chance” of approval by end of first quarter 2027. The prediction earned cheers from researchers, industry figures and enthusiasts.
Yet even a green light would not guarantee access. Doblin warned that a therapist shortage is “really acute.” “The amount of people who need this is astronomical,” he noted. “The VA has estimated there’s 13 million people in America with PTSD — so we have nowhere near the number of therapists we need.”
Dr. Dave Rabin, a trained MDMA psychotherapist and neuroscientist, echoed the concern. “Let’s just say we’re already behind,” he told The Post. “We really need to buckle ourselves in and get ready to create the infrastructure needed for continuing medical education programs. That’s the biggest challenge we’re going to have to overcome moving forward — other than insurance reimbursement.”
MAPS is pushing to fill the gap, with plans for its first US training session in December. “I think that once it’s approved, there’s going to be even more pressure to expand rapidly because the need is so great,” Doblin said. “But we should be very careful to expand only at the rate that we’ve got qualified therapists.”
The FDA declined to discuss the application’s status. “Under the law, the FDA is able to provide information on approved product applications. Information on an application that has not been approved, including an application yet to receive approval, generally is not releasable,” a spokesperson said in a statement to The Post.
